Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial
Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of deb...
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Gespeichert in:
| Autor*in: |
Nine de Graaf [verfasserIn] Anouk M. L. H. Emmen [verfasserIn] Marco Ramera [verfasserIn] Bergthor Björnsson [verfasserIn] Ugo Boggi [verfasserIn] Caro L. Bruna [verfasserIn] Olivier R. Busch [verfasserIn] Freek Daams [verfasserIn] Giovanni Ferrari [verfasserIn] Sebastiaan Festen [verfasserIn] Jony van Hilst [verfasserIn] Mathieu D’Hondt [verfasserIn] Benedetto Ielpo [verfasserIn] Tobias Keck [verfasserIn] Igor E. Khatkov [verfasserIn] Bas Groot Koerkamp [verfasserIn] Daan J. Lips [verfasserIn] Misha D. P. Luyer [verfasserIn] J. Sven D. Mieog [verfasserIn] Luca Morelli [verfasserIn] I. Quintus Molenaar [verfasserIn] Hjalmar C. van Santvoort [verfasserIn] Mirjam A. G. Sprangers [verfasserIn] Clarissa Ferrari [verfasserIn] Johannes Berkhof [verfasserIn] Patrick Maisonneuve [verfasserIn] Mohammad Abu Hilal [verfasserIn] Marc G. Besselink [verfasserIn] for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2023 |
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| Übergeordnetes Werk: |
In: Trials - BMC, 2006, 24(2023), 1, Seite 11 |
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| Übergeordnetes Werk: |
volume:24 ; year:2023 ; number:1 ; pages:11 |
| Links: |
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| DOI / URN: |
10.1186/s13063-023-07657-7 |
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| Katalog-ID: |
DOAJ091917646 |
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| 245 | 1 | 0 | |a Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial |
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| 520 | |a Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023 | ||
| 650 | 4 | |a Minimally invasive | |
| 650 | 4 | |a Laparoscopic | |
| 650 | 4 | |a Robot-assisted | |
| 650 | 4 | |a Pancreatoduodenectomy | |
| 650 | 4 | |a Whipple | |
| 650 | 4 | |a Pancreatic surgery | |
| 653 | 0 | |a Medicine (General) | |
| 700 | 0 | |a Anouk M. L. H. Emmen |e verfasserin |4 aut | |
| 700 | 0 | |a Marco Ramera |e verfasserin |4 aut | |
| 700 | 0 | |a Bergthor Björnsson |e verfasserin |4 aut | |
| 700 | 0 | |a Ugo Boggi |e verfasserin |4 aut | |
| 700 | 0 | |a Caro L. Bruna |e verfasserin |4 aut | |
| 700 | 0 | |a Olivier R. Busch |e verfasserin |4 aut | |
| 700 | 0 | |a Freek Daams |e verfasserin |4 aut | |
| 700 | 0 | |a Giovanni Ferrari |e verfasserin |4 aut | |
| 700 | 0 | |a Sebastiaan Festen |e verfasserin |4 aut | |
| 700 | 0 | |a Jony van Hilst |e verfasserin |4 aut | |
| 700 | 0 | |a Mathieu D’Hondt |e verfasserin |4 aut | |
| 700 | 0 | |a Benedetto Ielpo |e verfasserin |4 aut | |
| 700 | 0 | |a Tobias Keck |e verfasserin |4 aut | |
| 700 | 0 | |a Igor E. Khatkov |e verfasserin |4 aut | |
| 700 | 0 | |a Bas Groot Koerkamp |e verfasserin |4 aut | |
| 700 | 0 | |a Daan J. Lips |e verfasserin |4 aut | |
| 700 | 0 | |a Misha D. P. Luyer |e verfasserin |4 aut | |
| 700 | 0 | |a J. Sven D. Mieog |e verfasserin |4 aut | |
| 700 | 0 | |a Luca Morelli |e verfasserin |4 aut | |
| 700 | 0 | |a I. Quintus Molenaar |e verfasserin |4 aut | |
| 700 | 0 | |a Hjalmar C. van Santvoort |e verfasserin |4 aut | |
| 700 | 0 | |a Mirjam A. G. Sprangers |e verfasserin |4 aut | |
| 700 | 0 | |a Clarissa Ferrari |e verfasserin |4 aut | |
| 700 | 0 | |a Johannes Berkhof |e verfasserin |4 aut | |
| 700 | 0 | |a Patrick Maisonneuve |e verfasserin |4 aut | |
| 700 | 0 | |a Mohammad Abu Hilal |e verfasserin |4 aut | |
| 700 | 0 | |a Marc G. Besselink |e verfasserin |4 aut | |
| 700 | 0 | |a for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) |e verfasserin |4 aut | |
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10.1186/s13063-023-07657-7 doi (DE-627)DOAJ091917646 (DE-599)DOAJcb072ad779b24f5a9682de486711d25f DE-627 ger DE-627 rakwb eng R5-920 Nine de Graaf verfasserin aut Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023 Minimally invasive Laparoscopic Robot-assisted Pancreatoduodenectomy Whipple Pancreatic surgery Medicine (General) Anouk M. L. H. Emmen verfasserin aut Marco Ramera verfasserin aut Bergthor Björnsson verfasserin aut Ugo Boggi verfasserin aut Caro L. Bruna verfasserin aut Olivier R. Busch verfasserin aut Freek Daams verfasserin aut Giovanni Ferrari verfasserin aut Sebastiaan Festen verfasserin aut Jony van Hilst verfasserin aut Mathieu D’Hondt verfasserin aut Benedetto Ielpo verfasserin aut Tobias Keck verfasserin aut Igor E. Khatkov verfasserin aut Bas Groot Koerkamp verfasserin aut Daan J. Lips verfasserin aut Misha D. P. Luyer verfasserin aut J. Sven D. Mieog verfasserin aut Luca Morelli verfasserin aut I. Quintus Molenaar verfasserin aut Hjalmar C. van Santvoort verfasserin aut Mirjam A. G. Sprangers verfasserin aut Clarissa Ferrari verfasserin aut Johannes Berkhof verfasserin aut Patrick Maisonneuve verfasserin aut Mohammad Abu Hilal verfasserin aut Marc G. Besselink verfasserin aut for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) verfasserin aut In Trials BMC, 2006 24(2023), 1, Seite 11 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:24 year:2023 number:1 pages:11 https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/article/cb072ad779b24f5a9682de486711d25f kostenfrei https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 11 |
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10.1186/s13063-023-07657-7 doi (DE-627)DOAJ091917646 (DE-599)DOAJcb072ad779b24f5a9682de486711d25f DE-627 ger DE-627 rakwb eng R5-920 Nine de Graaf verfasserin aut Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023 Minimally invasive Laparoscopic Robot-assisted Pancreatoduodenectomy Whipple Pancreatic surgery Medicine (General) Anouk M. L. H. Emmen verfasserin aut Marco Ramera verfasserin aut Bergthor Björnsson verfasserin aut Ugo Boggi verfasserin aut Caro L. Bruna verfasserin aut Olivier R. Busch verfasserin aut Freek Daams verfasserin aut Giovanni Ferrari verfasserin aut Sebastiaan Festen verfasserin aut Jony van Hilst verfasserin aut Mathieu D’Hondt verfasserin aut Benedetto Ielpo verfasserin aut Tobias Keck verfasserin aut Igor E. Khatkov verfasserin aut Bas Groot Koerkamp verfasserin aut Daan J. Lips verfasserin aut Misha D. P. Luyer verfasserin aut J. Sven D. Mieog verfasserin aut Luca Morelli verfasserin aut I. Quintus Molenaar verfasserin aut Hjalmar C. van Santvoort verfasserin aut Mirjam A. G. Sprangers verfasserin aut Clarissa Ferrari verfasserin aut Johannes Berkhof verfasserin aut Patrick Maisonneuve verfasserin aut Mohammad Abu Hilal verfasserin aut Marc G. Besselink verfasserin aut for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) verfasserin aut In Trials BMC, 2006 24(2023), 1, Seite 11 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:24 year:2023 number:1 pages:11 https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/article/cb072ad779b24f5a9682de486711d25f kostenfrei https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 11 |
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10.1186/s13063-023-07657-7 doi (DE-627)DOAJ091917646 (DE-599)DOAJcb072ad779b24f5a9682de486711d25f DE-627 ger DE-627 rakwb eng R5-920 Nine de Graaf verfasserin aut Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023 Minimally invasive Laparoscopic Robot-assisted Pancreatoduodenectomy Whipple Pancreatic surgery Medicine (General) Anouk M. L. H. Emmen verfasserin aut Marco Ramera verfasserin aut Bergthor Björnsson verfasserin aut Ugo Boggi verfasserin aut Caro L. Bruna verfasserin aut Olivier R. Busch verfasserin aut Freek Daams verfasserin aut Giovanni Ferrari verfasserin aut Sebastiaan Festen verfasserin aut Jony van Hilst verfasserin aut Mathieu D’Hondt verfasserin aut Benedetto Ielpo verfasserin aut Tobias Keck verfasserin aut Igor E. Khatkov verfasserin aut Bas Groot Koerkamp verfasserin aut Daan J. Lips verfasserin aut Misha D. P. Luyer verfasserin aut J. Sven D. Mieog verfasserin aut Luca Morelli verfasserin aut I. Quintus Molenaar verfasserin aut Hjalmar C. van Santvoort verfasserin aut Mirjam A. G. Sprangers verfasserin aut Clarissa Ferrari verfasserin aut Johannes Berkhof verfasserin aut Patrick Maisonneuve verfasserin aut Mohammad Abu Hilal verfasserin aut Marc G. Besselink verfasserin aut for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) verfasserin aut In Trials BMC, 2006 24(2023), 1, Seite 11 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:24 year:2023 number:1 pages:11 https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/article/cb072ad779b24f5a9682de486711d25f kostenfrei https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 11 |
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10.1186/s13063-023-07657-7 doi (DE-627)DOAJ091917646 (DE-599)DOAJcb072ad779b24f5a9682de486711d25f DE-627 ger DE-627 rakwb eng R5-920 Nine de Graaf verfasserin aut Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023 Minimally invasive Laparoscopic Robot-assisted Pancreatoduodenectomy Whipple Pancreatic surgery Medicine (General) Anouk M. L. H. Emmen verfasserin aut Marco Ramera verfasserin aut Bergthor Björnsson verfasserin aut Ugo Boggi verfasserin aut Caro L. Bruna verfasserin aut Olivier R. Busch verfasserin aut Freek Daams verfasserin aut Giovanni Ferrari verfasserin aut Sebastiaan Festen verfasserin aut Jony van Hilst verfasserin aut Mathieu D’Hondt verfasserin aut Benedetto Ielpo verfasserin aut Tobias Keck verfasserin aut Igor E. Khatkov verfasserin aut Bas Groot Koerkamp verfasserin aut Daan J. Lips verfasserin aut Misha D. P. Luyer verfasserin aut J. Sven D. Mieog verfasserin aut Luca Morelli verfasserin aut I. Quintus Molenaar verfasserin aut Hjalmar C. van Santvoort verfasserin aut Mirjam A. G. Sprangers verfasserin aut Clarissa Ferrari verfasserin aut Johannes Berkhof verfasserin aut Patrick Maisonneuve verfasserin aut Mohammad Abu Hilal verfasserin aut Marc G. Besselink verfasserin aut for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) verfasserin aut In Trials BMC, 2006 24(2023), 1, Seite 11 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:24 year:2023 number:1 pages:11 https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/article/cb072ad779b24f5a9682de486711d25f kostenfrei https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 11 |
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10.1186/s13063-023-07657-7 doi (DE-627)DOAJ091917646 (DE-599)DOAJcb072ad779b24f5a9682de486711d25f DE-627 ger DE-627 rakwb eng R5-920 Nine de Graaf verfasserin aut Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023 Minimally invasive Laparoscopic Robot-assisted Pancreatoduodenectomy Whipple Pancreatic surgery Medicine (General) Anouk M. L. H. Emmen verfasserin aut Marco Ramera verfasserin aut Bergthor Björnsson verfasserin aut Ugo Boggi verfasserin aut Caro L. Bruna verfasserin aut Olivier R. Busch verfasserin aut Freek Daams verfasserin aut Giovanni Ferrari verfasserin aut Sebastiaan Festen verfasserin aut Jony van Hilst verfasserin aut Mathieu D’Hondt verfasserin aut Benedetto Ielpo verfasserin aut Tobias Keck verfasserin aut Igor E. Khatkov verfasserin aut Bas Groot Koerkamp verfasserin aut Daan J. Lips verfasserin aut Misha D. P. Luyer verfasserin aut J. Sven D. Mieog verfasserin aut Luca Morelli verfasserin aut I. Quintus Molenaar verfasserin aut Hjalmar C. van Santvoort verfasserin aut Mirjam A. G. Sprangers verfasserin aut Clarissa Ferrari verfasserin aut Johannes Berkhof verfasserin aut Patrick Maisonneuve verfasserin aut Mohammad Abu Hilal verfasserin aut Marc G. Besselink verfasserin aut for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) verfasserin aut In Trials BMC, 2006 24(2023), 1, Seite 11 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:24 year:2023 number:1 pages:11 https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/article/cb072ad779b24f5a9682de486711d25f kostenfrei https://doi.org/10.1186/s13063-023-07657-7 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 11 |
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Nine de Graaf @@aut@@ Anouk M. L. H. Emmen @@aut@@ Marco Ramera @@aut@@ Bergthor Björnsson @@aut@@ Ugo Boggi @@aut@@ Caro L. Bruna @@aut@@ Olivier R. Busch @@aut@@ Freek Daams @@aut@@ Giovanni Ferrari @@aut@@ Sebastiaan Festen @@aut@@ Jony van Hilst @@aut@@ Mathieu D’Hondt @@aut@@ Benedetto Ielpo @@aut@@ Tobias Keck @@aut@@ Igor E. Khatkov @@aut@@ Bas Groot Koerkamp @@aut@@ Daan J. Lips @@aut@@ Misha D. P. Luyer @@aut@@ J. Sven D. Mieog @@aut@@ Luca Morelli @@aut@@ I. Quintus Molenaar @@aut@@ Hjalmar C. van Santvoort @@aut@@ Mirjam A. G. Sprangers @@aut@@ Clarissa Ferrari @@aut@@ Johannes Berkhof @@aut@@ Patrick Maisonneuve @@aut@@ Mohammad Abu Hilal @@aut@@ Marc G. Besselink @@aut@@ for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) @@aut@@ |
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However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. 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Nine de Graaf Anouk M. L. H. Emmen Marco Ramera Bergthor Björnsson Ugo Boggi Caro L. Bruna Olivier R. Busch Freek Daams Giovanni Ferrari Sebastiaan Festen Jony van Hilst Mathieu D’Hondt Benedetto Ielpo Tobias Keck Igor E. Khatkov Bas Groot Koerkamp Daan J. Lips Misha D. P. Luyer J. Sven D. Mieog Luca Morelli I. Quintus Molenaar Hjalmar C. van Santvoort Mirjam A. G. Sprangers Clarissa Ferrari Johannes Berkhof Patrick Maisonneuve Mohammad Abu Hilal Marc G. Besselink for the European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS) |
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minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (diploma-2): study protocol for an international multicenter patient-blinded randomized controlled trial |
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Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial |
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Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023 |
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Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023 |
| abstract_unstemmed |
Abstract Background Minimally invasive pancreatoduodenectomy (MIPD) aims to reduce the negative impact of surgery as compared to open pancreatoduodenectomy (OPD) and is increasingly becoming part of clinical practice for selected patients worldwide. However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. Registered on August 2, 2023 |
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However, the safety of MIPD remains a topic of debate and the potential shorter time to functional recovery needs to be confirmed. To guide safe implementation of MIPD, large-scale international randomized trials comparing MIPD and OPD in experienced high-volume centers are needed. We hypothesize that MIPD is non-inferior in terms of overall complications, but superior regarding time to functional recovery, as compared to OPD. Methods/design The DIPLOMA-2 trial is an international randomized controlled, patient-blinded, non-inferiority trial performed in 14 high-volume pancreatic centers in Europe with a minimum annual volume of 30 MIPD and 30 OPD. A total of 288 patients with an indication for elective pancreatoduodenectomy for pre-malignant and malignant disease, eligible for both open and minimally invasive approach, are randomly allocated for MIPD or OPD in a 2:1 ratio. Centers perform either laparoscopic or robot-assisted MIPD based on their surgical expertise. The primary outcome is the Comprehensive Complication Index (CCI®), measuring all complications graded according to the Clavien-Dindo classification up to 90 days after surgery. The sample size is calculated with the following assumptions: 2.5% one-sided significance level (α), 80% power (1-β), expected difference of the mean CCI® score of 0 points between MIPD and OPD, and a non-inferiority margin of 7.5 points. The main secondary outcome is time to functional recovery, which will be analyzed for superiority. Other secondary outcomes include post-operative 90-day Fitbit™ measured activity, operative outcomes (e.g., blood loss, operative time, conversion to open surgery, surgeon-reported outcomes), oncological findings in case of malignancy (e.g., R0-resection rate, time to adjuvant treatment, survival), postoperative outcomes (e.g., clinically relevant complications), healthcare resource utilization (length of stay, readmissions, intensive care stay), quality of life, and costs. Postoperative follow-up is up to 36 months. Discussion The DIPLOMA-2 trial aims to establish the safety of MIPD as the new standard of care for this selected patient population undergoing pancreatoduodenectomy in high-volume centers, ultimately aiming for superior patient recovery. Trial registration ISRCTN27483786. 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